MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX; GCJ

Model Number CTF73

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report represents the initial and final report.

Event Description

Procedure performed: prostatectomy with da vinci robot.Event description: the ctf73 trocar was used as camera port (da vinci si laparoscope port) during prostatectomy.When inserting the laparoscope into the trocar the laparoscope did not get through the seal housing.The laparoscope then was pushed with force through the seal housing and the port was used during the whole surgery but every time the laparoscope was pulled out for cleaning and inserted into the trocar again this was done by force due to the high friction.Unfortunately the trocar was thrown away but the lot number was saved.The same incident happened on monday during the same type of surgery with da vinci but both the trocar and the lot number were thrown away.[reference mw #2027111-2018-00151].Additional information received from the sales rep by email on 26 mar 2018: patient status is without remark since the patient was not affected of this.The only remark would be that the surgery time was a little bit longer due to the problem with the seal housing.Additional information received from the sales rep by email on 4 apr 2018: da vinci si robot laparoscope was used.There is only one size which is more than 10 mm.Type of intervention: a ctf73 trocar from the same lot was used on same purpose and procedure on the same day but there was not any problems.Patient status: no patient injury or illness occurred associated with the complaint event.

• Brand Name: CTF73, 12X100 KII FIOS ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7422460
• MDR Text Key: 105655597
• Report Number: 2027111-2018-00150
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)201024(30)01(10)1308716
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2020
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1308716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1